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• CapsoView software: intended for the download of
images from CapsoCam Plus capsules, generation of video
files, review of videos, annotation of images, and
generation of reports.
• CapsoAccess Capsule Data Access System: intended for
accessing data from the CapsoCam Plus capsule.
• CapsoCloud cloud-based software: intended to manage
patient' s CapsoCam Plus exam images and to review and
analyze images (select countries only).
Ratings
IP68
Type BF applied part
3.1V DC battery-powered
10mA
Class IIa
Device Common Name
System, Imaging, Gastrointestinal, Wireless, Capsule
Operating Range
Device operates in vivo. Ex vivo it operates within the
following environmental ranges—
Temperature: 5°-40° C
Humidity: 5% to 95%
Atmospheric Pressure: 59kPa to 105kPa
Document Number: IFU-2320 Rev: J Revision Date: 08/2020
Operating Environment
The intended use environments for CapsoCam Plus are home
healthcare environment, hospital, transport and ambulatory
environments.
Contraindications
The CapsoCam Plus capsule is contraindicated in patients:
• Who have known or suspected gastrointestinal
obstructions, strictures or fistula.
• Who are pregnant.
• Who have gastroparesis.
• Who have a swallowing disorder.
Patient Condition
The physician should consider performing a small bowel
series before utilizing this device in patients who are
suspected to have strictures or fistulas. See Risks on Page 4
for additional risks related to specific patient conditions.
Adverse Events
Potential adverse events associated with the use
of this device may include:
• Obstruction, perforation, and mucosal injury or bleeding.
• Aspiration of the capsule.
• Delayed or no excretion of the capsule.
• In some instances, intervention is required to remove
the capsule.
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